The Assessment of Spirituality Between Cancer and Chronic Inpatients: A Cross-Sectional Study

PurposeSpiritual well-being had protective effect on quality of life in cancer, due to the cultural, regional and custom differences,it was rarely been discussed between cancer and chronic diseases in Chongqing,China. We aimed at comparing the level of spirituality in two groups, and discussing its factors of subjects with cancer at county regions.MethodsA cross-sectional questionnaire survey was distributed to 630 inpatients who received treatment between January and December 2020 in Chongqing University Three Gorges Hospital.In addition to basic demographic data,spirituality was measured using the Chinese version of Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp-12). The mean,standard deviation,independent t-tests, ANOVA and multiple regression were used for statistical description and analysis.ResultsSignificant differences were found between cancer and chronic diseases in total scores of FACIT-Sp-12 and each domain(P<0.05).The meaning, peace, faith and total scores in cancer were 11.21±3.38,10.66±4.46,11.43±3.54,and 33.3±10.35,respectively.Which were lower than chronic diseases (13.00±3.21,12.95±4.76,12.66±3.64,38.61±10.88,respectively). The spiritual well-being had significant differences in gender,character,and emotional with spouse for cancer (P<0.05).The male and extravert character were significantly associated with a greater spiritual well-being.ConclusionThe study shows a medium level of spiritual well-being in cancer, which stands the population with lower economic and education in county regions. It suggests that under the current nursing mode, we should provide specifically spiritual care to the female,introvert and those with poor relationship with spouses, and create a harmonious doctor-patient environment to improve the spiritual well-being.Retrospectively registeredJSCC-D-21-01528,17 Sep 2021

Espiritualidade, Religiosidade, Distress e Qualidade de Vida em Pacientes Oncológicos

O presente estudo teve o objetivo de avaliar a relação entre o distress, a qualidade de vida e a prática espiritual e religiosa (ER) em pacientes recém-diagnosticados com câncer, na primeira linha de tratamento quimioterápico. Trata-se de um estudo transversal, que avaliou 100 pacientes quanto ao distress (Termômetro de Distress), qualidade de vida (Functional Assessment of Chronic Illness Therapy – General) e espiritualidade (Functional Assessment of Chronic Illness Therapy – Spiritual Well-Being Scale e Escala de Religiosidade da Universidade de Duke). Os resultados sugerem que a prática ER é uma importante estratégia no enfrentamento do diagnóstico e tratamento do câncer, estando associada significativamente a um menor nível de distress, melhor qualidade de vida e melhor bem-estar espiritual.

Intradialytic Exercise: Flexibility terhadap Skor Fatigue pada Pasien Penyakit Ginjal Kronis yang Menjalani Hemodialisis

Penyakit Ginjal Kronis (PGK) mengalami peningkatan dalam 5 tahun terakhir ini. Salah satu terapi pengganti ginjal adalah hemodialisis, di mana fatigue merupakan gejala yang paling umum dirasakan oleh pasien yang mengganggu aktivitas sehari-hari dan kualitas hidupnya. Pengelolaan dengan intradialytic exercise: flexibility perlu dilakukan karena tidak menggangu proses terapi dan ini jarang dilakukan. Tujuan penelitian ini adalah mengetahui pengaruh intradialytic exercise: flexibility terhadap skor fatigue pada pasien yang menjalani hemodialisis. Penelitian ini adalah pre-eksperimen dengan pendekatan one group pre-test post-test design. Sampel penelitian sebanyak 20 orang dipilih menggunakan teknik purposive sampling. Instrumen yang digunakan adalah kuesioner functional assessment chronic illness therapy (FACIT) dan prosedur intradialytic exercise: flexibility. Pengumpulan data dilakukan dengan mengukur skor fatique sebelum dan setelah diberikan perlakuan. Perlakuan berupa latihan fisik dengan durasi 15 menit setiap sesi latihan selama 8 kali dalam 4 minggu. Analisis data menggunakan t-test. Hasil penelitian didapatkan nilai rerata pre-test 25,70 dan post-test 30,75 yang menunjukkan terjadi peningkatan skor fatigue dan nilai p < 0,001 yang artinya terdapat pengaruh intradialytic exercise: flexibility terhadap skor fatigue. Simpulan, terdapat pengaruh intradialytic exercise: flexibility yang baik terhadap skor fatigue pada pasien PGK yang menjalani hemodialisis.Kata kunci : Flexibility; Hemodialisis; Intradialytic Exercise; Penyakit Ginjal Kronis

Rationale and design of the EPCHF trial: the early palliative care in heart failure trial (EPCHF)

The progressive nature of heart failure (HF) coupled with high mortality and poor quality-of-life (QoL) mandates greater attention to palliative care (PC) as a routine component of HF management. Limited evidence exists from randomized controlled trials supporting the use of interdisciplinary palliative care in the progressive course of HF. The early palliative care in heart failure trial (EPCHF) is a prospective, controlled, nonblinded, multicenter study of an interdisciplinary palliative care intervention in 200 patients with symptomatic HF characterized by NYHA ≥ 2. The 12-month EPCHF intervention includes monthly consultations by a palliative care team focusing on physical and psychosocial symptom relief, attention to spiritual concerns and advance care planning. The primary endpoint is evaluated by health-related QoL questionnaires after 12 months of treatment. First the functional assessment of chronic illness therapy palliative care (FACIT-Pal) score evaluating QoL living with a chronic disease and second the Kansas City cardiomyopathy questionnaire (KCCQ) measuring QoL living with heart failure will be determined. Secondary endpoints are changes in anxiety/depression (HADS), symptom burden score (MIDOS), spiritual well-being functional assessment of chronic illness therapy spiritual well-being scale (FACIT-Sp), medical resource and cost assessment. EPCHF will help evaluate the efficacy and cost-effectiveness of palliative care in symptomatic HF using a patient-centered outcome as well as clinical and economic endpoints. EPCHF is funded by the Bundesministerium für Bildung und Forschung (BMBF, 01GY17).

Functional assessment of cancer therapy questionnaire for melanoma in the Serbian population: A factor analytic approach

The aim of this study was to examine the psychometric properties of the Functional Assessment Cancer Therapy—Melanoma (FACT-M) questionnaire in the Serbian language. The FACT-M was translated into Serbian using the standard methodology after obtaining the licence from the Functional Assessment of Chronic Illness Therapy (FACIT) translation project team. This version of FACT-M was distributed to a cohort of consecutive patients with histologically confirmed high-risk skin melanoma treated at the tertiary referral center. To examine construct validity of the FACT-M in Serbian, we performed exploratory factor analysis (EFA) and confirmatory factor analysis (CFA). The FACT-General (FACT-G) did not fit the original 4-domain structure. Instead, we accepted a 7-domain structure which, aside from physical, emotional, social and functional well-being, had domains of ‘friends’ support’, ‘illness acceptance’ and ‘fear of death’. Melanoma scale (MS) and Melanoma surgery scale (MSS) did not fit the original one-dimensional structure. The MS was observed to have 4 domains: ‘pain’, ‘skin problems’, ‘abdominal metastases’ and ‘other problems’. The MSS was observed to have 2 domains: ‘having symptoms’ and ‘no symptoms’. It is suggested that the FACT-M questionnaire is analyzed using the newly extracted domains to examine quality of life of people with high-risk melanoma in Serbia.

Relationship between disease activity level and physical activity in rheumatoid arthritis using a triaxial accelerometer and self-reported questionnaire

Objective This study evaluated the relationship between rheumatoid arthritis (RA) disease activity level and physical activity (PA) by using an accelerometer and self-reported questionnaire. Results The cross-sectional study was part of a cohort study designed to determine disease activity is associated with PA in RA patients. We classified patients with a Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) of less than and higher than 3.2 into the low-disease-activity (LDA) group and moderate/high-disease-activity (MHDA) group, respectively. We measured the wear time, time of vigorous-intensity PA, moderate-intensity PA, light-intensity PA, and sedentary behavior per day using a triaxial accelerometer. 34 patients were included in the study. The accelerometer-measured moderate-to-vigorous PA (MVPA) was 17.2 min/day and 10.6 min/day in the LDA group and MHDA group (p < 0.05), respectively. There was no significant association between RA disease activity level and accelerometer-measured PA with adjustment for age and Functional Assessment of Chronic Illness Therapy-Fatigue score. There was no correlation between accelerometer-measured MVPA and self-reported MVPA in the MHDA group, but these factors were correlated in the LDA group (rs = 0.57, p < 0.05). In conclusion, no significant association was noted between RA disease activity level and accelerometer-measured PA.

Norm Values and Psychometric Properties of the 24-Item Demoralization Scale (DS-I) in a Representative Sample of the German General Population

Purpose: The Demoralization scale (DS-I) is a validated and frequently used instrument to assess existential distress in patients with cancer and other severe medical illness. The purpose of this study was to provide normative values derived from a representative German general population sample and to analyze the correlational structure of the DS-I.Methods: A representative sample of the adult German general population completed the DS-I (24 Items), the Emotion Thermometers (ET) measuring distress, anxiety, depression, anger, need for help, and the Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-fatigue).Results: The sample consists of N = 2,407 adults (mean age = 49.8; range = 18–94 years), 55.7% women). The percentages of participants above the DS-I cutoff (≥30) was 13.5%. The mean scores of the DS-I dimensions were as follows: (1) loss of meaning and purpose: M = 2.78 SD = 4.49; (2) disheartenment: M = 3.19 SD = 4.03; (3) dysphoria M = 4.51 SD = 3.20; (4) sense of failure: M = 6.24 SD = 3.40; and for the DS-I total score: M = 16.72 SD = 12.74. Women reported significantly higher levels of demoralization than men, with effect sizes between d = 0.09 (Loss of Meaning) and d = 0.21 (Dysphoria). Age was not associated with demoralization in our sample. DS-I reliability was excellent (α = 0.94) and DS-I subscales were interrelated (r between 0.31 and 0.87) and significantly correlated with ET, especially depression, anxiety, and need for help and fatigue (r between 0.14 and 0.69).Conclusions: In order to use the DS-I as a screening tool in clinical practice and research the normative values are essential for comparing the symptom burden of groups of patients within the health care system to the general population. Age and sex differences between groups of patients can be accounted for using the presented normative scores of the DS-I.

OP0239 PSYCHOMETRIC EVALUATION OF FUNCTIONAL ASSESSMENT OF CHRONIC ILLNESS THERAPY-FATIGUE IN PATIENTS WITH ACTIVE ANKYLOSING SPONDYLITIS

Background:Due to its impact on their health-related quality of life (QoL), fatigue is considered a core domain of disease assessment in patients (pts) with ankylosing spondylitis (AS). Psychometric data analyses in pts with rheumatoid and psoriatic arthritis have previously demonstrated that the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) is a reliable and valid measure in these pt populations,1,2 but there are limited data supporting the psychometric validity and reliability of the FACIT-F scale in adult pts with active AS.Objectives:To further evaluate the psychometric properties of the FACIT-F scale in adult pts with active AS.Methods:This post hoc analysis used data from the Phase (P)2 (NCT01786668, Study 1) and P3 (NCT03502616, Study 2) studies of tofacitinib in pts with active AS. Second-order confirmatory analysis (CFA) evaluated the measurement model of FACIT-F with two domains (Experience and Impact) and the total score at baseline (BL) and the studies’ respective primary analysis time points, Week (W)12 (Study 1) or W16 (Study 2). At the same time points, internal consistency reliability was examined by Cronbach’s Coefficient alpha (α), and convergent validity was assessed through correlations of FACIT-F domain and total scores with a set of pt-reported outcomes (PROs): Pt Global Assessment of Disease Activity (PtGA), total back pain/nocturnal spinal pain due to AS, Short Form-36 Health Survey (SF-36v2), Bath AS Functional Index, Bath AS Disease Activity Index and ASQoL. Test-retest reliability was assessed by calculating Intraclass Correlation Coefficients (ICCs). The known-groups validity assessment was derived from an anchor-based repeated measures longitudinal model, with PtGA scores as the anchor (PtGA represented pt state from ‘no disease activity’ to ‘very active disease’ [PtGA=0 and 10, respectively]), and FACIT-F domain/total scores as the outcome. Estimations of ability to detect change and meaningful within-pt change (MWPC) were derived from anchor-based repeated measures longitudinal models, with change from BL in PtGA scores as the anchor and change from BL in FACIT-F domain/total scores as the outcome.Results:The CFA model fit the data well (Bentler’s Comparative Index ≥0.92 at BL, W12 [Study 1] and W16 [Study 2]), supporting the measurement model of the FACIT-F scale in pts with AS. Across time points in each study, the FACIT-F domain and total scores demonstrated excellent internal consistency (Cronbach’s Coefficient α ≥0.88), and correlations between FACIT-F domain/total scores, and all PROs assessed generally exceeded 0.40. Generally, in both studies, the largest correlations (0.62–0.85) were between FACIT-F domain/total scores and the SF-36v2 vitality domain score and ASQoL. Test-retest reliability was acceptable for all FACIT-F domain/total scores (ICC ranged from 0.75–0.89 in both studies). An approximately linear relationship was observed between FACIT-F total scores and PtGA scores in both studies (Figure), as well as for Experience and Impact domain scores. The differences in FACIT-F domain/total scores were large and statistically significant between ‘no disease activity’ and ‘very active disease’ pt groups (standardised effect size ≥1.17), supporting known-groups validity. Ability to detect change was evidenced by an approximately linear relationship between changes in PtGA and FACIT-F domain/total scores in both studies; when pts experienced a change in PtGA, values for FACIT-F domain/total scores changed accordingly. Conservatively, MWPC was estimated as 6.3 for FACIT-F total score, and 2.8 and 3.6 for FACIT-F Experience and Impact domain scores, respectively.Conclusion:This quantitative analysis of data from two clinical studies of tofacitinib demonstrates the validity and reliability of the FACIT-F scale in adult pts with active AS. Therefore, these findings support the use of FACIT-F in AS studies.References:[1]Cella et al. J Rheumatol 2005; 32: 811-819.[2]Cella et al. J Patient Rep Outcomes 2019; 3: 30.Acknowledgements:Study sponsored by Pfizer Inc. Medical writing support was provided by Kirsten Woollcott, CMC Connect, and funded by Pfizer Inc.Disclosure of Interests:David Cella Consultant of: AbbVie, Alexion Pharmaceuticals, Astellas Pharma, Bayer, Bristol-Myers Squibb, Clovis Oncology, Evidera, Exelixis, Horizon Therapeutics, Janssen, Merck/Schering-Plough, National Academy of Sciences, Novartis Pharma K.K. (Japan), Pfizer Inc, PledPharma and Regeneron, William Lenderking Shareholder of: Pfizer Inc, Employee of: Evidera, Peter Chongpinitchai Employee of: Evidera, Andrew G Bushmakin Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Oluwaseyi Dina Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Lisy Wang Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Joseph C Cappelleri Shareholder of: Pfizer Inc, Employee of: Pfizer Inc, Victoria Navarro-Compán Speakers bureau: AbbVie, Janssen, Eli Lilly, MSD, Pfizer Inc, UCB, Consultant of: AbbVie, Janssen, Eli Lilly, MSD, Pfizer Inc, UCB, Grant/research support from: AbbVie, Novartis

AB0541 PREDICTING THE INITIATION OF BIOLOGIC DMARDS IN EARLY PSORIATIC ARTHRITIS WITHIN 1-YEAR OF TREAT-TO-TARGET STRATEGY

Background:According to the EULAR recommendations and treat-to-target (T2T) strategy synthetic (s) DMARDs are the first-line of PsA therapy and biologic (b) DMARDs are the second one [1]. The value of early intervention by bDMARDs in PsA has been demonstrated recently [2]. But factors which can predict bDMARDs initiation have not been evaluated yet.Objectives:To identify prognostic factors for initiation of bDMARDs within 1-year of T2T strategy in early PsA.Methods:70 patients (pts) (M/F=35/35) with active early PsA fulfilling the CASPAR criteria treated by T2T strategy were included. Mean age 36.9±10.2 years (yrs), PsA duration 11.3±10.6 months (mos.), psoriasis duration 80.6±89.9 mos. Median DAPSA= 29.4 [23.1;36.0]. At baseline (BL) all pts were given therapy with Methotrexate (MTX) s/c with escalating dose from 5 to 25 mg/wk, then over a period of 12 mos pts with ineffectiveness of MTX were added bDMARDs. At BL and every 3 month of therapy all pts underwent standard clinical examinations of PsA activity. DAPSA, ESR (mm/h), CRP (mg/l), the number of pts with dactylitis, enthesitis by LEI and plantar fascia, BSA (%), HAQ and fatigue by FACIT (Functional Assessment of Chronic Illness Therapy) Fatigue Scale (Version 4), BMI (kg/m2) were evaluated. DAPSA > 28 indicate high activity, a score FACIT < 30 - severe fatigue, BMI >25 overweight and obese. At 12 mos. pts were divided into two groups. Group 1 included 42 pts who were treated with MTX only and group 2 - 28 pts those with added bDMARDs during 12 mos. Multi-dimensional step-by-step discriminant analysis was used to identify a group of signs associated with the need to initiate bDMARDs within 12 mos.Results:Comparative analysis of two groups showed the following features proved to be the most informative at BL and at 3 mos. of sDMARDs therapy with MTX: high PsA activity by DAPSA ≥ 30 (р = 0.009), BMI (kg/m2) ≥ 27 (р = 0.019), entesitis ≥ 1 (p= 0.005), ESR ≥ 20 mm/h (p= 0.007), FACIT < 30 (p= 0.074), male sex (р = 0.098). Early PsA pts with combination of these features at the first visit and at 3 mos. of MTX monotherapy have more chance to initiate bDMARDs in comparison to pts without them. Area Under ROC Curve (AUC) 0.892; 95% CI (0.818-0.966). Sensitivity/ Specificity of model 82% / 76% accordingly. (Figure 1).Figure 1.Conclusion:It is a combination of features from first visit to clinic and at 3 mos. of MTX monotherapy – high PsA activity by DAPSA, male gender, persistent entesitis, obesity, ESR increase and severe fatigue by FACIT - that constitutes a prognostic factor for the initiation of bDMARDs at an early-stage of PsA. These factors should be considered in clinical practice to avoid losing time for the early initiation of bDMARDs and improved outcomes of PsA.References:[1]Gossec L, et al. Ann Rheum Dis. 2020;79:700–712. doi:10.1136/annrheumdis-2020-217159. 2. van Mens LJJ, et al. Ann Rheum Dis 2019;78:610–616. doi:10.1136/annrheumdis-2018-214746Disclosure of Interests:None declared.